Can a meningitis vaccine be safe in pregnancy? a registry aims to find out
NCT ID NCT07768163
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This registry study follows pregnant individuals aged 10 to 25 who received PENBRAYA, a vaccine against meningococcal disease, during pregnancy or within 30 days before their last period. The goal is to collect information on pregnancy outcomes and infant health during the first year of life, including birth defects, preterm birth, and growth. No extra tests or visits are needed—data is gathered remotely from participants and their doctors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PENBRAYA (meningococcal vaccine)
- What this could lead to
- If this registry finds no safety concerns, it could support the use of PENBRAYA in pregnant individuals, protecting them and their babies from meningococcal disease.
- What could go wrong
- This is a small observational registry, not a controlled trial, so it may not detect rare or long-term effects. The vaccine's safety in pregnancy is still not fully established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Apr 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will include a single cohort of pregnant individuals in the US exposed to PENBAYA during pregnancy or within the 30 days prior to their last menstrual period
- Ages
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10 to 25 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion * Currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome) * Received at least one dose of PENBRAYA during pregnancy or within 30 days prior to last menstrual period (LMP) * Personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent, indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study * Authorization for the enrolled participants' health care provider(s) (HCP\[s\]) to provide data to the registry * Contact information (for participant and HCPs) Exclusion \- None
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Pfizer New York
RECRUITINGNew York, New York, 10001, United States
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